Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Supplement containing horse-derived elastin peptides Administration: Two tablets per day, taken between lunch and bedtime
Duration: 12 weeks Test product: Placebo
Sponsors
BIOCON (JAPAN) LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults (aged >= 40 and < 70 years) 4. Healthy individuals 5. Individuals whose FMD is >= 4% and < 7% at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to horse-derived substances 7. Individuals who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} every day 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 10. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of flow-mediated dilation (FMD) at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change in FMD from screening to 12w 2. The measured values of maximum vessel dilation, resting vessel diameter, and brachial-ankle pulse wave velocity (baPWV) at 12w, and their changes and percentage changes from screening 3. The measured values of systolic blood pressure and diastolic blood pressure at 12w 4. The measured values of each item from the original questionnaire at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed